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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLOC SAFETY INFUSION SET 20G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR
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C.R. BARD, INC. (BASD) -3006260740 POWERLOC SAFETY INFUSION SET 20G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number N/A
Device Problems Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 01/17/2023
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A batch history review (bhr) of asfxf902 showed no other similar product complaint(s) from this batch number.Device not returned for evaluation.
 
Event Description
It was reported by the customer that tubing from needle has been disconnected from the luer attachment.Patient experienced some blood loss after the tubing was disconnected.The device was being used for oncology treatment so there was potential for exposure to cytotoxic products.Additional information received 2/3/2023: customer reported that "there was no adverse impact on the patient and no further treatment was required.".
 
Event Description
It was reported by the customer that tubing from needle has been disconnected from the luer attachment.Patient experienced some blood loss after the tubing was disconnected.The device was being used for oncology treatment so there was potential for exposure to cytotoxic products.Additional information received 2/3/2023: customer reported that "there was no adverse impact on the patient and no further treatment was required.".
 
Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The complaint of a detached luer hub was confirmed and the cause appeared to be supplier-related.The product returned for evaluation was one 20ga x 0.75¿ powerloc safety infusion set.Usage residues were observed and the safety mechanism was engaged.The luer was completely detached from the extension tubing.Tactile inspection of the sample did not reveal any tensile weakness.Inspection of the extension tubing and luer using an ultraviolet light revealed no adhesive residue on the distal end of the tubing.No adhesive residue was observed within the luer.The observed detachment appeared to be the result of insufficient adhesive at the tubing/luer.It appeared that inadequate adhesive was applied during the assembly process.The device is a supplied component and the supplier has been notified of this event.
 
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Brand Name
POWERLOC SAFETY INFUSION SET 20G X 0.75IN
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
Manufacturer (Section G)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
Manufacturer Contact
kayla olsen
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key16387876
MDR Text Key309679487
Report Number3006260740-2023-00472
Device Sequence Number1
Product Code FPA
UDI-Device Identifier00801741048333
UDI-Public(01)00801741048333
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K060812
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/26/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number8652034
Device Lot NumberASFXF902
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/25/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/23/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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